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510(k) K935688

AN-10S ANDERSEN TUBE WITH STYLET by H.W. Andersen Products, Inc. — Product Code BSS

K935688 is an FDA 510(k) premarket notification submitted by H.W. Andersen Products, Inc. for the device "AN-10S ANDERSEN TUBE WITH STYLET". The FDA issued a decision of Substantially Equivalent on December 30, 1994. The device falls under product code BSS (Tube, Nasogastric), a Class II device regulated under 21 CFR 876.5980. H.W. Andersen Products, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1994
Date Received
November 29, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Nasogastric
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Other clearances by H.W. Andersen Products, Inc.

  • K872458 — AN3200 DOUBILET DRAIN (September 21, 1987)
  • K872460 — AN3000 MAHONEY DRAIN (July 23, 1987)
  • K872457 — AN3500 WORTH DRAIN (July 21, 1987)
  • K872459 — AN3100 MULHOLLAND DRAIN (July 21, 1987)

Other clearances for product code BSS

  • K142483 — TurboSEAL Nasogastric Aspiration Tube (December 19, 2014)
  • K051480 — ENTERAL FEEDING TUBE (October 12, 2005)
  • K984629 — MOSS TUBES, INC. NASAL TUBE - MARK IV (March 2, 1999)
  • K961711 — ASPISAFE GASTRIC TUBE (June 11, 1997)
  • K933596 — GASTRIC, CATHETER, IRRIGATION & ASPIRATION (February 13, 1995)
  • K930510 — RADIUS ENTERAL FEEDING TUBE (February 1, 1995)
  • K934348 — TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE SIZES 18FR, 22FR, 32FR (December 23, 1994)
  • K905573 — XEMEX ENTERAL NUTRITION CATHETER NASOGAS. TYPE A (June 19, 1991)
  • K910479 — ARGYLE POLYURETHANE SALEM SUMP TUBE (April 19, 1991)
  • K894870 — WILTEK NASAL BILIARY DRAINAGE SET (December 21, 1989)

FDA data resources